510(k) K060277
K060277 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 3, 2006. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Boehringer Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2006
- Date Received
- February 2, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type